Table 3.
Trial enrichment example—tabulation of predicted probabilities of observing a 30% decline of eGFR as a function of baseline TKV, eGFR, or age
| Time (yr) | Predicted probabilities of a 30% decline of eGFR |
|||||
|---|---|---|---|---|---|---|
| Baseline TKV (ml) |
Baseline eGFR (ml/min per 1.73 m2) |
Baseline age (yr) |
||||
| ≥1000 | <1000 | <50 | ≥50 | ≥40 | ≥40 | |
| 1 | 1.75% | 0.85% | 1.41% | 1.20% | 1.32% | 1.29% |
| 2 | 3.97% | 1.97% | 3.20% | 2.74% | 3.01% | 2.93% |
| 3 | 9.88% | 5.09% | 8.03% | 6.94% | 7.61% | 7.36% |
| 4 | 15.8% | 8.40% | 12.9% | 11.3% | 12.3% | 11.9% |
| 5 | 20.8% | 11.3% | 17.1% | 15.0% | 16.3% | 15.8% |
| 6 | 25.2% | 14.1% | 20.8% | 18.4% | 20.0% | 19.3% |
| 7 | 34.8% | 20.3% | 29.0% | 26.1% | 28.0% | 27.1% |
| 8 | 42.9% | 26.2% | 36.2% | 33.0% | 35.0% | 34.1% |
| 9 | 48.0% | 30.1% | 40.7% | 37.4% | 39.5% | 38.6% |
| 10 | 53.1% | 34.3% | 45.3% | 42.0% | 44.1% | 43.2% |
These results suggest that, when eGFR is preserved, patients with larger TKV are more likely to progress to a 30% decline of eGFR within the course of a clinical trial, whereas eGFR and age displayed limited predictive value of disease progression in early disease.
eGFR, estimated glomerular filtration rate; TKV, total kidney volume.